Access to Care Pilot for ED-Presenting Head and Neck Cancer Patients (ENRICH-HNC)

Part of paid clinical trials in Orlando, Florida.

Sponsor
University of Tennessee
Study ID
NCT07225725
Status
Not Yet Recruiting

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Conditions

  • Emergency Department Presentation
  • Head and Neck Cancer (H&N)
  • Head and Neck Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Community Health Support Specialist (CHSS) Navigation — BEHAVIORAL
    This intervention consists of structured, non-clinical navigation delivered by trained Community Health Support Specialists (CHSS) as part of the Engaging Navigators to Reduce Inequities in Cancer Health (ENRICH) program. Following emergency department discharge and completion of electronic informed consent, CHSS staff conduct outreach by telephone or text message to identify and address social and logistical barriers to timely head and neck cancer care. Navigation activities may include assistance with transportation resources, insurance or financial navigation, connection to housing or community services, and reinforcement of communication between patients and clinical care teams. CHSS staff do not provide medical advice, schedule clinical appointments, or alter treatment plans. All navigation encounters are documented using standardized REDCap instruments.

Study Details

Patients diagnosed with head and neck cancer (HNC) after presenting to an emergency department (ED) often face significant delays in diagnosis and treatment. These patients are frequently younger, underinsured, and experience multiple socioeconomic and systems-level barriers to accessing timely cancer care. Delays of more than 30 days have been associated with worse outcomes, including higher recurrence rates and reduced survival. This pilot study will evaluate the feasibility and early impact of a community-based navigation program designed to improve access to timely care for ED-presenting HNC patients. The study embeds trained Community Health Support Specialists (CHSS) from the Engaging Navigators to Reduce Inequities in Cancer Health (ENRICH) program into the ED-to-treatment pathway. After ED discharge, CHSS staff will contact participants by telephone or text message to identify barriers to care-such as transportation, insurance, housing, or communication challenges-and connect them with appropriate community or institutional resources. All participants will receive the CHSS navigation intervention. Outcomes will be compared with a historical cohort of similar ED-presenting HNC patients treated prior to program implementation. The primary outcomes are time from ED discharge to diagnostic biopsy and time from ED discharge to initiation of definitive treatment. Secondary outcomes include feasibility, measured as the proportion of participants who complete CHSS navigation, and exploratory analyses of the types of barriers identified and resolved. Findings from this pilot will generate preliminary data to inform larger studies aimed at improving access, reducing disparities, and accelerating treatment for head and neck cancer patients who first present in the emergency setting.

Key Dates

Start date
Feb 1, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Community Health Support Specialist (CHSS) Navigation
    Participants will receive structured, non-clinical navigation support from a trained Community Health Support Specialist (CHSS) initiated after emergency department discharge. CHSS outreach will occur by telephone or text message and will focus on identifying social and logistical barriers to timely cancer care (e.g., transportation, insurance, housing, communication), providing appropriate resource referrals, and reinforcing communication between patients and clinical care teams as needed. Each participant will receive a minimum of two CHSS contacts prior to initiation of definitive cancer treatment.

Primary Outcome Measure

Time From Emergency Department (ED) Presentation to Diagnostic Biopsy (Days) [ Time Frame: Up to 90 days after ED discharge ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Methodist University HospitalOrlandoFlorida32819
Justin M Soffer, MD
[email protected]
321-287-7574
Regional One HealthMemphisTennessee38103
Justin M Soffer, MD
321-287-7574

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By research site
Methodist University Hospital· Orlando, FLRegional One Health· Memphis, TN

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